IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC.
`Patent Owner.
`
`_____________________
`
`CASE: IPR2018-00608
`U.S. Pat. No. 9,161,926
`_____________________
`
`PETITIONERS’ DEMONSTRATIVE EXHIBITS
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC.
`Patent Owner.
`
`_____________________
`
`CASE: IPR2018-00608
`U.S. Pat. No. 9,161,926
`_____________________
`
`PETITIONERS’ DEMONSTRATIVE EXHIBITS
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Amneal v. Almirall
`IPR2018-00608
`Amneal Demonstratives
`
`Petitioners Amneal Pharmaceuticals, LLC and Amneal
`Pharmaceuticals of New York, LLC
`U.S. Patent No. 9,161,926
`
`Oral Hearing
`June 5, 2019
`
`Honorable Sheridan K. Snedden,
`Grace Karaffa Obermann, and Christopher G. Paulraj
`
`Amneal Demonstrative 1
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 2
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 3
`
`
`
`Independent claims 1 and 5
`
`’926
`patent
`
`AMN1001 (“’926 patent”), claims 1 and 5
`
`Amneal Demonstrative 4
`
`
`
`Dependent claims 2 and 3 align claim 1 with claim 5,
`while claims 4 and 6 add a preservative
`
`’926
`patent
`
`AMN1001 (“’926 patent”), claims 2-4 and 6
`
`Amneal Demonstrative 5
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 6
`
`
`
`Almirall’s proposed construction of “dapsone” does
`not resolve any dispute
`
`POR, 31
`
`POR
`
`Amneal Demonstrative 7
`
`
`
`Almirall tries to manufacture a controversy where
`none exists
`
`POR
`
`POR, 40
`
`Amneal Demonstrative 8
`
`
`
`Dapsone’s synonyms are well-known
`
`Garrett
`
`AMN1004, 10:27-34; Pet., 8; AMN1004, 8:17-22; AMN1050, ¶¶ 5, 7; Pet. Rep., 9; EX2003, ¶ 47; POR, 7-8
`
`Amneal Demonstrative 9
`
`
`
`Garrett expressly disclosed “dapsone” exactly as
`construed by Almirall
`
`Almirall’s
`construction
`(POR)
`
`Garrett
`
`AMN1004, 8:18-22; Pet. Reply, 9; AMN1059, 17:65:6-9; POR, 31
`
`Amneal Demonstrative 10
`
`
`
`The ’926 patent draws the same distinction as Garrett
`between dapsone and its derivatives
`
`Garrett
`
`POR
`
`AMN1004, 11:1-12; POR, 31; Pet. Rep., 9-10
`
`Amneal Demonstrative 11
`
`
`
`Garrett refers to Aczone Gel 5%, which contains
`4,4’-diaminodiphenyl sulfone
`
`Garrett
`
`Aczone Gel
`5% Label
`
`Almirall’s
`construction
`
`AMN1004, 10:6-7; AMN1010, 1; Pet. Reply , 9; POR, 31
`
`Amneal Demonstrative 12
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 13
`
`
`
`Garrett’s preferred embodiment taught almost every
`limitation of claims 1 and 5
`
`’926
`patent
`
`AMN1001, claim 5; AMN1004, 4:2-5; Pet. 21-30
`
`No mention of
`adapalene
`
`Garrett
`
`Amneal Demonstrative 14
`
`
`
`Garrett’s preferred embodiment also taught the
`dependent claims
`
`’926
`patent
`
`AMN1001, claims 2-4, 6; AMN1004, 4:2-5; Pet. 38-39
`
`Garrett
`
`Amneal Demonstrative 15
`
`
`
`Dapsone was useful to treat inflammatory and non-
`inflammatory acne
`
`Garrett
`
`Aczone Gel
`5% Label
`
`AMN1004, 2:9-15; AMN1010, 3; Pet., 24
`
`Amneal Demonstrative 16
`
`
`
`Garrett taught the claimed dapsone concentration
`
`’926
`patent
`
`Garrett
`
`Petition
`
`AMN1004, 4:2-5; AMN1001, claim 5; Pet. 24-25
`
`Amneal Demonstrative 17
`
`
`
`DGME was both a “preferred” solubilizing agent and
`the one used in the prior-art dapsone product
`
`’926
`patent
`
`Garrett
`
`Aczone Gel
`5% Label
`
`AMN1004, 14:13-14; AMN1010, 1; AMN1002, ¶ 52, Pet. 27
`
`Amneal Demonstrative 18
`
`
`
`Garrett taught adjusting DGME amount, because it is a
`results-effective variable
`
`Petition
`
`AMN1004, 18:17-23; AMN1002, ¶ 52; AMN1050, ¶ ¶ 28-30; Pet. 26-29; Pet. Rep., 16-17
`
`Garrett
`
`Amneal Demonstrative 19
`
`
`
`Garrett’s DGME range overlaps the amounts claimed
`in ’926 patent
`
`’926
`patent
`
`AMN1001, claim 5; AMN1004, 3:33-4:15; Pet. 27-29
`
`Garrett
`
`Amneal Demonstrative 20
`
`
`
`Sepineo P 600 (“Sepineo”) is the claimed A/SA
`copolymer
`
`*
`
`*
`
`*
`
`Nadau‐Fourcade
`
`AMN1005, 47:12-33
`
`Amneal Demonstrative 21
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 22
`
`
`
`Nadau-Fourcade taught the claimed A/SA copolymer
`
`Garrett
`
`…
`
`Nadau‐Fourcade
`
`AMN1004, 13:3-6; Pet., 14; AMN1005, 47:12-33; Pet., 32
`
`Amneal Demonstrative 23
`
`
`
`A POSA would have known that Sepineo was
`interchangeable with Carbopol
`
`Michniak‐Kohn
`
`This case presents a strong case of obviousness based on the prior
`art references of record. … [A]ll that was required to obtain th[e
`claimed] combination was to substitute one well‐known [gelling
`agent] for another.”
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012)
`
`AMN1002, ¶57; Pet. 31; Pet. Rep., 22
`
`Amneal Demonstrative 24
`
`
`
`Almirall did not dispute that Sepineo and Carbopol
`are interchangeable
`
`Michniak‐Kohn
`
`Klibanov
`
`AMN1002, ¶57; Pet., 12-13; EX2003, ¶175
`
`Amneal Demonstrative 25
`
`
`
`Almirall told a U.S. District Court that Sepineo and
`Carbopol are interchangeable
`
`District Court Claim Construction R&R
`
`Almirall LLC v. Taro Pharm. Indus. LTD., Civ. No. 17-663 (D. Del.), D.I. 87, 2; Pet. Rep., 21
`
`Amneal Demonstrative 26
`
`
`
`The Board’s Institution Decision in the IPR on the
`related ’219 patent supports interchangeability
`
`PTAB ’219 patent Institution Decision
`
`AMN1060, 22
`
`Amneal Demonstrative 27
`
`
`
`Garrett’s preferred thickener concentration overlaps
`with the claims
`
`’926
`patent
`
`Garrett
`
`AMN1004, 13:10-11; Pet. 33-34; AMN1001, claim 5
`
`Amneal Demonstrative 28
`
`
`
`Nadau-Fourcade’s preferred thickener concentration
`overlaps with the claims
`
`’926
`patent
`
`Nadau‐Fourcade
`
`AMN1005, 11:8-9; Pet. 35; AMN1001, claim 5
`
`Amneal Demonstrative 29
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claims 1 and 5
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`A topical pharmaceutical
`composition comprising:
`
`Garrett
`. . .
`“The present invention provides a pharmaceutical
`carrier system comprising a dermatological
`composition that is a semi‐solid aqueous gel…”
`
`“The present invention provides methods … [of]
`treatment [] directed to dermatological conditions
`and the treatment is provided by a topical dapsone
`composition.”
`
`“Topical Dapsone Compositions: The present
`invention comprises compositions for application to
`the skin of G6PD‐deficient patients.”
`
`Amneal Demonstrative 30
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claims 1 and 5
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`[a] about 7.5% w/w
`dapsone;
`
`[1b] about 30% w/w to
`about 40% w/w diethylene
`monoethyl ester;
`[5b] about 30% w/w
`diethylene glycol
`monoethyl ether;
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 31
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claims 1 and 5
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`[1c] about 2% w/w to
`about 6% w/w of a
`polymeric viscosity builder
`consisting of
`acrylamide/sodium
`acryloyldimethyl taurate
`copolymer;
`[5c] about 4% w/w of a
`polymeric viscosity builder
`consisting of
`acrylamide/sodium
`acryloyldimethyl taurate
`copolymer
`
`Garrett
`. . .
`“Thickening agents include polymer thickeners. Polymer
`thickeners that may be used include those known to one
`skilled in the art, such as hydrophilic and hydroalcoholic
`gelling agents frequently used in the cosmetic and
`pharmaceutical industries.”
`
`“Preferably, the gelling agent comprises between about
`0.2% to about 4% by weight of the composition.”
`
`Nadau‐Fourcade
`. . .
`“Preferred gelling agents include carbomers, for instance
`Carbopol 980® or 981®, polyarylamides, for instance
`Sepineo P 600® or Simulgel 600 PHA®, and
`polysaccharides, for instance xantham gum.”
`
`Amneal Demonstrative 32
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claims 1 and 5
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`[d] and water;
`
`[e] wherein the
`composition does not
`comprise adapalene.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2%
`water; about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 33
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claim 2
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`The composition of claim 1,
`wherein the diethylene
`glycol monoethyl ether is
`present at a concentration
`of about 30% w/w
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 34
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claim 3
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`The composition of claim 1,
`wherein the polymeric
`viscosity builder is present
`at a concentration of about
`4% w/w.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Nadau‐Fourcade
`. . .
`“Preferred gelling agents include carbomers, for instance
`Carbopol 980® or 981®, polyarylamides, for instance
`Sepineo P 600® or Simulgel 600 PHA®, and
`polysaccharides, for instance xantham gum.”
`
`Amneal Demonstrative 35
`
`
`
`Ground 1: ’926 claims obvious over Garrett in view of
`Nadau-Fourcade
`
`Claims 4 and 6
`
`Garrett (AMN1004), Nadau‐Fourcade (AMN1005)
`
`The composition of claim
`[1 or 5], further comprising
`methyl paraben.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water;
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 36
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 37
`
`
`
`Dapsone/Carbopol formulations were gritty
`
`Aczone Gel
`5% Label
`
`AMN1010, 1; Pet., 46-47
`
`Amneal Demonstrative 38
`
`
`
`A POSA had reason to use Sepineo to obtain smooth
`formulations
`
`Bonacucina
`
`AMN1015, 7; AMN1026, 2; AMN1002, ¶ 84; Pet., 47
`
`Sepineo P
`600 leaflet
`
`Amneal Demonstrative 39
`
`
`
`A POSA had reason to replace Carbopol with Sepineo
`to reduce the particle size of undissolved dapsone
`
`AMN1007, [0049]; Pet. Rep., 24; AMN1050, ¶ 49
`
`Lathrop
`
`Amneal Demonstrative 40
`
`
`
`Carbopol required neutralization with a base to
`function as a thickener
`
`Lubrizol Data Sheet
`
`AMN1020, 2; AMN1002, ¶82; Pet., 48
`
`Michniak‐Kohn
`
`Amneal Demonstrative 41
`
`
`
`Sepineo would simplify the manufacturing process by
`avoiding a neutralization step
`
`Sepineo P
`600 leaflet
`
`AMN1026, 2; AMN1002, ¶ 84; Pet., 48
`
`Amneal Demonstrative 42
`
`
`
`Garrett’s preferred thickener concentration overlaps
`with the claims
`
`’926
`patent
`
`Garrett
`
`AMN1004, 13:10-11; Pet. 33-34; AMN1001, claim 5
`
`Amneal Demonstrative 43
`
`
`
`Bonacucina’s preferred thickener concentration
`overlaps with the claims
`
`’926
`patent
`
`Bonacucina
`
`AMN1015, 7; Pet. 49; AMN1001, claim 5
`
`Amneal Demonstrative 44
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claims 1 and 5
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`A topical pharmaceutical
`composition comprising:
`
`Garrett
`. . .
`“The present invention provides a pharmaceutical carrier
`system comprising a dermatological composition that is a
`semi‐solid aqueous gel…”
`
`“The present invention provides methods … [of] treatment
`[] directed to dermatological conditions and the treatment
`is provided by a topical dapsone composition.”
`
`“Topical Dapsone Compositions: The present invention
`comprises compositions for application to the skin of
`G6PD‐deficient patients.”
`
`Amneal Demonstrative 45
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claims 1 and 5
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`[a] about 7.5% w/w
`dapsone;
`
`[1b] about 30% w/w to
`about 40% w/w diethylene
`monoethyl ester;
`[5b] about 30% w/w
`diethylene glycol
`monoethyl ether;
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 46
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claims 1 and 5
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`[1c] about 2% w/w to
`about 6% w/w of a
`polymeric viscosity builder
`consisting of
`acrylamide/sodium
`acryloyldimethyl taurate
`copolymer;
`[5c] about 4% w/w of a
`polymeric viscosity builder
`consisting of
`acrylamide/sodium
`acryloyldimethyl taurate
`copolymer;
`
`Garrett
`. . .
`“Thickening agents include polymer thickeners. Polymer
`thickeners that may be used include those known to one
`skilled in the art, such as hydrophilic and hydroalcoholic
`gelling agents frequently used in the cosmetic and
`pharmaceutical industries.”
`
`“Preferably, the gelling agent comprises between about
`0.2% to about 4% by weight of the composition.”
`
`Bonacucina
`. . .
`“Sepineo® P 600, based on the concept of droplet
`hydroswelling, is a concentrated droplet dispersion of
`acylamide/sodium acryloyldimethyl taurate (a viscous
`liquid at room temperature) in isohexadecane as the oily
`dispersing phase.”
`
`Amneal Demonstrative 47
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claims 1 and 5
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`[d] and water;
`
`[e] wherein the
`composition does not
`comprise adapalene.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2%
`water; about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 48
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claim 2
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`The composition of claim 1,
`wherein the diethylene
`glycol monoethyl ether is
`present at a concentration
`of about 30% w/w.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 49
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claims 3
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`The composition of claim 1,
`wherein the polymeric
`viscosity builder is present
`at a concentration of about
`4% w/w.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water,
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Bonacucina
`. . .
`“Sepineo® P 600, based on the concept of droplet
`hydroswelling, is a concentrated droplet dispersion of
`acylamide/sodium acryloyldimethyl taurate (a viscous
`liquid at room temperature) in isohexadecane as the oily
`dispersing phase.”
`
`Amneal Demonstrative 50
`
`
`
`Ground 2: ’926 claims obvious over Garrett in view of
`Bonacucina
`
`Claims 4 and 6
`
`Garrett (AMN1004), Bonacucina (AMN1015)
`
`The composition of claim
`[1 or 5], further comprising
`methyl paraben.
`
`Garrett
`. . .
`“In one preferred embodiment, the composition includes
`about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water;
`about 10% to 30% ethoxydiglycol; about 0.2%
`methylparaben; about 5% to 10% dapsone in a
`microparticulate and dissolved state; and about 0.1% to 2%
`sodium hydroxide solution.”
`
`Amneal Demonstrative 51
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 52
`
`
`
`Based on Amneal’s showing, the claims are prima
`facie obvious
`
`“A prima facie case of obviousness typically exists when the
`ranges of a claimed composition overlap the ranges disclosed
`in the prior art. We have said that such overlap creates a
`presumption of obviousness.”
`
`E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir.
`2018) (internal quotations, citations, and modifications omitted)
`
`Only four ways for Almirall to salvage its
`prima facie invalid claims (id.):
`• Show unexpected results that are different in kind;
`• Show teaching away;
`• Show that the parameter was not recognized as
`“result‐effective.”
`• Show that a very broad disclosure does not invite
`optimization.
`
`Reply, 13
`
`Amneal Demonstrative 53
`
`
`
`Almirall is wrong: there was no teaching away from
`the claimed invention
`
`“This court has further explained that just because better
`alternatives exist in the prior art does not mean that an
`inferior combination is inapt for obviousness purposes.”
`
`In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012).
`
`The “mere disclosure of more than one alternative does
`not amount to teaching away from one of the
`alternatives where the [prior art] does not ‘criticize,
`discredit, or otherwise discourage the solution claimed.”
`
`SightSound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1320 (Fed. Cir. 2015).
`
`Pet. Rep., 4
`
`Amneal Demonstrative 54
`
`
`
`Almirall is wrong: a POSA would have considered
`dapsone at the time of invention
`
`Morris
`
`Kraft
`
`AMN1008, ¶[0004]; EX2024, 5; EX2041, 1; AMN1034, ¶9; Pet. Rep., 5-6
`
`Ghods
`
`Amneal Demonstrative 55
`
`
`
`Almirall is wrong: the art as a whole showed that
`dapsone was an effective acne treatment
`
`Aczone Gel
`5% Label
`
`Lathrop
`
`AMN1010, 1; AMN1007, [0003]; Pet., 8
`
`Amneal Demonstrative 56
`
`
`
`Almirall is wrong: Even its expert Dr. Harper was
`investigating dapsone in 2012
`
`Harper Dec
`
`Harper
`
`EX2022, 60; AMN1035, 1; Pet. Rep., 7
`
`Amneal Demonstrative 57
`
`
`
`Almirall is wrong: Dr. Harper “believed”
`in dapsone in 2012
`
`Harper Depo.
`
`AMN1049, 30:115:24-30:116:10
`
`Amneal Demonstrative 58
`
`
`
`Almirall is wrong: Dr. Harper received substantial sums
`of money for her time promoting Aczone Gel 5%
`
`Dr. Harper’s total
`compensation from
`Patent Owner:
`$213,344.70 to
`$232,342.70
`
`Harper Depo.
`AMN1049, 10:34:5-7; AMN1049, 12:42:2-4; AMN1049, 42:163:7-19; AMN1041-1048; Pet. Opp. to Mtn. to Exclude
`
`Amneal Demonstrative 59
`
`
`
`Almirall is wrong: Amneal doesn’t need to show a
`motivation to use 7.5% dapsone
`
`Garrett
`
`“A prima facie case of obviousness typically exists when the ranges of a
`claimed composition overlap the ranges disclosed in the prior art. We
`have said that such overlap creates a presumption of obviousness.”
`
`E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018)
`(internal quotations, citations, and modifications omitted)
`
`AMN1004, 15:10-14; Pet. 31; Pet. Rep., 22
`
`Amneal Demonstrative 60
`
`
`
`Almirall is wrong: a POSA had reason to optimize
`amount of dapsone to achieve once-daily dosing
`
`Aczone Gel
`5% Label
`
`Garrett
`
`Harper Dec
`
`AMN1010, 9; AMN1004, 23:8-12; Pet. Rep. 14-15; EX2002, ¶ 152
`
`Amneal Demonstrative 61
`
`
`
`Almirall is wrong: a POSA would not have been
`dissuaded by any speculative safety concerns
`
`Garrett
`
`“[C]aution [is] not a prohibition.”
`
`Accord Healthcade Inc. v. Daiichi Sankyo Co., Ltd.,
`IPR2015-00865, Paper 104, 17 (Sept. 12, 2016).
`
`AMN1004, 4:2-5, 6:5-8, 42:25-32; AMN1050, ¶ 17; Pet. Rep., 13-14
`
`Amneal Demonstrative 62
`
`
`
`Almirall is wrong: Aczone Gel 7.5% data confirms
`the prior art
`
`Aczone Gel 5% twice daily
`
`Aczone Gel 7.5% once daily
`
`415 ± 224 ng∙h/ml
`
`282 ± 146 ng∙h/ml
`
`Garrett
`
`AMN1010, 1; EX2039, 5; AMN1004, 5:5-8; AMN1050, ¶¶ 19-20; Pet. Rep., 14
`
`Amneal Demonstrative 63
`
`
`
`Almirall is wrong: optimized dissolved / undissolved
`ratio in Aczone 5% does not teach away from 7.5%
`
`POR
`
`AMN1009, 4; POR, 27; Pet Rep., 13-14
`
`Amneal Demonstrative 64
`
`
`
`Almirall is wrong: increased dapsone concentration
`would have led to the claimed range of DGME
`
`Osbourne
`
`POR, 27; AMN1009, 4; Pet. Reply, 17; AMN1009, 3; AMN1050, ¶28
`
`Amneal Demonstrative 65
`
`
`
`Almirall is wrong: by 2012, there were no toxicity
`concerns about using DGME
`
`Sullivan
`
`AMN1053, 9; Pet. Rep., 18
`
`Amneal Demonstrative 66
`
`
`
`Almirall is wrong: even Dr. Harper encouraged the use
`of DGME with dapsone to treat acne
`
`AMN1035, 4-5; Reply, 7
`
`Harper
`
`Amneal Demonstrative 67
`
`
`
`Almirall is wrong: the ’926 patent and Garrett exclude
`adapalene in exactly the same way
`
`Prosecution History
`
`Garrett
`
`AMN1017, 316; AMN1004, 3:9-15; Pet. Rep., 18
`
`Amneal Demonstrative 68
`
`
`
`Almirall is wrong: its expert, Dr. Klibanov, agreed that
`Garrett taught exclusion of adapalene
`
`AMN1058, 5:17:4-24; Reply, 19
`
`Klibanov Depo.
`
`Amneal Demonstrative 69
`
`
`
`Almirall is wrong: Dr. Harper testified that retinoids are
`all interchangeable
`
`Harper Depo.
`
`AMN1049, 21:80:11-81:4; Reply, 19
`
`Amneal Demonstrative 70
`
`
`
`Almirall is wrong: the “consisting of” language limits
`only the type of PVB, not other excipients
`
`’926
`patent
`
`“The reasonable interpretation of the claims
`containing both of the terms ‘comprising’ and
`‘consist[ing]’ is that the term ‘consisting’ limits” only
`the term to which it is applied.
`
`AMN1004, claim 1; Pet. Rep., 10
`
`In re Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004).
`
`Amneal Demonstrative 71
`
`
`
`Almirall is wrong: the specification contemplates
`Sepineo (A/SA, isohexadecane, Polysorbate 80)
`
`’926
`patent
`
`AMN1001, 5:35-38, Examples 1-5; AMN1015, 2; Pet. Rep., 11
`
`Amneal Demonstrative 72
`
`
`
`Almirall is wrong: the prosecution history contradicts
`exclusion of Sepineo
`
`…
`
`Prosecution History
`
`Presumption that “consisting of” is closed is overcome when
`the prosecution history “unmistakeably manifest[s] an
`alternative meaning.”
`Shire Development, LLC v. Watson Pharmas., Inc., 848 F.3d 981, 984 (Fed. Cir. 2017).
`
`AMN1017, 349, 351; Pet. Rep., 11-12
`
`Amneal Demonstrative 73
`
`
`
`Almirall is wrong: even its expert Dr. Klibanov said
`Sepineo is covered by the claims
`
`EX2003, ¶¶ 203, 206; Pet. Rep., 10-11
`
`Klibanov
`
`Amneal Demonstrative 74
`
`
`
`Almirall is wrong: the 4% PVB limitation refers to the
`total amount of Sepineo, not A/SA copolymer
`
`AMN1058, 29:111:10-112:8; Pet. Rep., 1
`
`Klibanov Depo.
`
`Amneal Demonstrative 75
`
`
`
`Almirall is wrong: Dr. Klibanov’s evasive testimony
`undercuts his credibility
`
`Klibanov
`
`EX2003, ¶ 203; AMN105828:106:1-5; Pet. Rep., 1, 10-11
`
`Klibanov Depo.
`
`Amneal Demonstrative 76
`
`
`
`Almirall is wrong: Dr. Klibanov’s evasive testimony
`undercuts his credibility (cont.)
`
`Klibanov Depo.
`
`AMN1058, 28:106:12-107:9; Pet. Rep., 1
`
`Amneal Demonstrative 77
`
`
`
`Almirall is wrong: Dr. Klibanov’s evasive testimony
`undercuts his credibility (cont.)
`
`Klibanov Depo.
`
`AMN1058, 29:110:13-21; Pet. Rep., 1
`
`Amneal Demonstrative 78
`
`
`
`Almirall is wrong: Nadau-Fourcade is not
`incompatible with Garrett
`
`Nadau‐Fourcade
`
`AMN1005, 42:1-2; AMN1005, 42:33-43:4; Reply, 20-21
`
`Amneal Demonstrative 79
`
`
`
`Almirall is wrong: Nadau-Fourcade’s fatty phase does
`not include isohexadecane or polysorbate 80
`
`AMN1005, 44; Sur-Reply, 17-18
`
`Nadau‐Fourcade
`
`Amneal Demonstrative 80
`
`
`
`Overview
`
`1. Claims 1-6 of the ’926 patent
`
`2. Almirall’s claim construction argument is a red herring
`
`3. The claims are prima facie obvious
`
`a. Garrett, Nadau-Fourcade, and Bonacucina teach every
`limitation of all claims.
`b. Ground 1: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Nadau-Fourcade.
`c. Ground 2: Claims 1-6 of the ’926 patent are unpatentable
`over Garrett and Bonacucina.
`
`4. All of Almirall’s arguments fail to rebut prima facie
`obviousness and contradict its statements elsewhere
`
`5. Almirall did not even allege objective indicia of
`nonobviousness
`
`Amneal Demonstrative 81
`
`
`
`Almirall’s argument that Sepineo is not covered by the
`claims forecloses any objective indicia
`
`POR
`
`’219 Prosecution History
`
`POR, 3; AMN1031, 8; Pet., 19
`
`Amneal Demonstrative 82
`
`
`
`Even absent a waiver, the Board’s recent Institution
`Decision supports unpatentability
`
`PTAB ’219 patent Institution Decision
`
`AMN1031, 8; Pet., 19; AMN1060, 20
`
`Amneal Demonstrative 83
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)
`
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`
`Demonstrative Exhibits”, were served in their entirety on June 3, 2019, upon the
`
`Elizabeth B. Hagen
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`following parties via email:
`
`
`
`
`
`
`
`
`
`
`
`James Trainor
`Vanessa Park-Thompson
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`vpark-thompson@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwick.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`
`
` Dennies Varughese (Reg. No. 61,868)
`
`Date: June 3, 2019
`
` Lead Counsel for Petitioners
`
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`
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`
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